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Recce Advances Phase 3 Diabetic Foot Trial and Strengthens Anti-Infective Pipeline

Story Highlights
  • Recce is progressing a large Phase 3 trial in Indonesia for its RECCE 327 gel to treat diabetic foot infections, targeting up to 310 patients under expedited regulatory review to secure approval in a high-burden, high-cost market.
  • The company reported promising preclinical results for inhaled RECCE 327 against drug-resistant hospital pneumonia, while bolstering its patent protection and winning up to AUD 85 million in R&D support, enhancing its anti-infective pipeline and funding base.
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Recce Advances Phase 3 Diabetic Foot Trial and Strengthens Anti-Infective Pipeline

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An announcement from Recce Pharmaceuticals Ltd. ( (AU:RCE) ) is now available.

Recce Pharmaceuticals reported significant operational progress in its second quarter of FY2026, advancing its registrational Phase 3 clinical trial of RECCE 327 topical gel for diabetic foot infections in Indonesia, one of the world’s largest and fastest-growing diabetes markets. The study, targeting up to 310 patients with an interim analysis at 155 patients and expedited regulatory review from Indonesian authorities, is designed to meet rigorous clinical endpoints using the FDA-recognised Lipsky Scale, positioning the company for a potential major approval in a high-cost, high-need indication. In parallel, Recce announced positive preclinical efficacy data for inhaled RECCE 327 in a murine model of hospital- and ventilator-acquired pneumonia caused by carbapenem-resistant Acinetobacter baumannii, demonstrating both therapeutic benefit and the practical advantage of effective nebulisation over existing last-resort antibiotics like meropenem. Additional milestones during the quarter included the grant of a Hong Kong patent for its anti-infective portfolio and a substantial AusIndustry advanced overseas R&D finding of up to AUD 85 million to support its synthetic anti-infective development program, collectively strengthening its intellectual property, funding position, and strategic footing in the global anti-infective market.

The most recent analyst rating on (AU:RCE) stock is a Hold with a A$0.71 price target. To see the full list of analyst forecasts on Recce Pharmaceuticals Ltd. stock, see the AU:RCE Stock Forecast page.

More about Recce Pharmaceuticals Ltd.

Recce Pharmaceuticals Ltd is an ASX- and FSE-listed biotechnology company focused on developing a new class of synthetic anti-infective therapies. Its lead candidates, including RECCE 327 in topical gel and inhaled formulations, target severe and resistant infections such as diabetic foot infections and hospital- or ventilator-acquired pneumonia, with a particular emphasis on addressing growing global antimicrobial resistance and high-burden markets like Southeast Asia.

Average Trading Volume: 130,631

Technical Sentiment Signal: Buy

Current Market Cap: A$189.4M

For a thorough assessment of RCE stock, go to TipRanks’ Stock Analysis page.

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